Pilot Study of Maraviroc/Raltegravir for Naive HIV-1 Patients

NCT01291459 | Unknown Phase 2 DMC

• 1 other identifier: 2009/HD/01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 12

Brief Summary

Background and Rationale Raltegravir and Maraviroc, the first in class of 2 new families of antiretroviral drugs have demonstrated a high potency in treatment experienced and naive patients. Both drugs appeared well tolerated with low metabolic toxicity. No data are currently available concerning the combination of these 2 drugs. Hypothesis Maraviroc + Raltegravir should be potent enough to maintain virological efficacy in naive patients infected by CCR5 HIV-1 previously treated for 6 months with a Maraviroc-Raltegravir-Tenofovir-Emtricitabine combination.

Conditions

HIV

Keywords

HIV; naive patients; maraviroc; raltegravir

Outcome Measures

Primary Outcomes (1)

• HIV-1 viral load

  measure of HIV viral load at 48 weeks of treatment for all patients

  48 weeks

Study Arms (1)

single arm

EXPERIMENTAL

Maraviroc/raltegravir/emtricitabine/tenofovir 24 weeks followed by Maraviroc/Raltegravir 24 weeks

Drug: MVC/RAL/FTC/TDF followed by Maraviroc/Raltegravir

Interventions

MVC/RAL/FTC/TDF followed by Maraviroc/Raltegravir DRUG

MVC/RAL/FTC/TDF 24W followed by MVC/RAL until W48.

Also known as: Maraviroc, Raltegravir, Emtricitabine, Tenofovir

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old at the run-in visit
• HIV-1 infection
• Antiretroviral treatment-naive
• CD4 ≥ 200 /mm3
• HIV- RNA ≥ 1000 copies/ml
• HIV-RNA ≤ 100,000 copies/ml
• Antiretroviral therapy is indicated according to current guidelines
• CCR5-tropic virus according to the Trofile ES® assayGeno2Pheno algorithm using a predefined false positive rate of 20%
• No significant NRTI, NNRTI or PI resistance mutation
• Freely-given, written, informed consent obtained; the patient and investigator have signed the consent form (by the latest on the day of the run-in visit and before performing any examinations required by the trial)
• Patient covered by a French national health insurance scheme

You may not qualify if:

• Women of child-bearing potential not using effective contraception (barrier method)
• Pregnant or breast-feeding women
• Patients under the age of 18 years
• Patients deprived of liberty by a judicial or administrative, hospitalized patients without consent, patients admitted to a health or social purposes other than research
• Persons major subject of a measure of legal protection or unable to consent
• Previous antiretroviral therapy (with the exception of post-exposure prophylaxis if HIV serology is negative \> 3 months after the last dose of antiretroviral drugs)
• CXCR4-tropic virus, dual/mixed-tropic virus or undetermined tropism on screening
• Presence of significant NRTI, NNRTI or PI resistance mutation(s)
• Infection or co-infection with HIV-2, or group O or N HIV-1
• Acute phase of an opportunistic infection
• Undergoing treatment for tuberculosis
• Undergoing chemotherapy and/or radiotherapy for neoplastic disease
• Decompensated cirrhosis (Child-Pugh class B or C)
• HIV-HBV co-infection. Patients with HIV-HCV co-infection are permitted to participate in the absence of decompensated cirrhosis (Child-Pugh class B or C), of hepatocytolysis \> 3 times the upper limit of normal and if treatment for HCV during the ensuing 12 months is not indicated. PAtients with occult HBV are excluded.( positive AcHBc, negative AcHBs, negative AgHBs, positive HBV DNA)
• Co-administration of prohibited treatments (see the SPCs of each product) Laboratory parameters: Haemoglobin \< 7g/dl, neutrophil count \< 500/mm3, platelet count \< 50,000/mm3, creatinine clearance \< 50 ml/min, alkaline phosphatase, AST, ALT or bilirubin ≥ 3 times upper limit of normal

Sponsors & Collaborators

• Association Pour la Recherche en Infectiologie: lead

Study Sites (12)

Cannes hosipital

Cannes, 06400, France

Location

CHU

Clermont-Ferrand, 63003, France

Location

Frejus hospital

Fréjus, 83608, France

Location

Edourad Herriot hospital

Lyon, 69003, France

Location

Croix Rousse hospital

Lyon, 69004, France

Location

Ste MArguerite Hospital

Marseille, 13009, France

Location

Conception hospital

Marseille, 13385, France

Location

Hotel Dieu hospital

Nantes, 44093, France

Location

Hopital l'Archet 1

Nice, 06202, France

Location

St Louis Hospital

Paris, 75010, France

Location

Pitie Salpetriere Hospital

Paris, 75013, France

Location

Nord Hospital

Saint-Etienne, 42277, France

Location

MeSH Terms

Interventions

Raltegravir Potassium; Maraviroc; Emtricitabine; Tenofovir

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Organophosphonates; Organophosphorus Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Laurent COTTE, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 26, 2011
• First Posted: February 8, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 30, 2015

Record last verified: 2015-12

Locations

FR (12)